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Clinical Trials

The Department of Otolaryngology—Head & Neck Surgery is actively involved in ground-breaking research in the areas of hearing loss, tissue engineering, and head and neck cancer. Clinical trials help us translate our research into patient care. For a full list of available clinical trials, visit Columbia RecruitMe

What is a Clinical Trial?

A clinical trial is a research study using human volunteers, which is intended to add to medical knowledge. Participants receive a specific intervention, such as a medical strategy, treatment, or device, to determine whether it is safe and effective for humans. Clinical trials are the best way to understand the risks and benefits to humans of any given medical strategy, treatment, or device.

A clinical trial is one of the final stages of a long research process, which may begin in a laboratory and involve testing on animals.

The trial must follow strict scientific standards which protect participants and help produce reliable study results. It also has to undergo a rigorous process of review and approval by the Food and Drug Administration (FDA) and by an Institutional Review Board (IRB), which is an independent committee of physicians, researchers and members of the community charged with ensuring that the study is ethical and that the rights and welfare of participants are protected.

The trial usually begins with a small group of participants who have undergone a thorough process of informed consent. The trial may go through several phases. Ultimately, the trial will determine if a new strategy, treatment, or device improves patient outcomes, offers no benefits, or causes unexpected harm. All of these results are important because they advance medical knowledge and improve patient care.

Why Enroll in a Clinical Trial?

Benefits of participation in a clinical trial include:

Access to innovative treatments and state-of-the-art care before it is available outside the clinical trial setting

Opportunities to take a more active role in one’s own health care

Regular, consistent medical care and close monitoring by a team of health professionals during the course of study participation

Contribution to advancements in medical research

How to Enroll in a Clinical Trial

Clinical trials have specific criteria, called inclusion and exclusion criteria, which are used to determine your eligibility for a trial. These criteria may include age, gender, medical history, or medical conditions. A candidate must match all of the specified criteria in order to participate in the trial.

Once your eligibility has been confirmed, our research coordinator will begin the informed consent process. This is the process by which researchers provide potential participants with information about a clinical study to help them decide whether they want to enroll in the study. This information includes:

The reason for the trial

Expected length of the study

Who may participate in the study (the eligibility criteria)

The number of participants needed

The schedule of tests, procedures, or drugs and their dosages

The length of the study

Risks and benefits

What information will be gathered about the participants

You will also have the opportunity to ask any questions about the study that you may have. Once you have reviewed the information and have all of your questions answered, you will be asked to sign a consent form. The consent document is not a contract. Participants may withdraw from a study at any time, even if the study is not over.